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The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery.

Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain

Generally recognized indications for operative hysteroscopy include:

• Directed endometrial biopsy
• Polypectomy
• Submucous myomectomy
• Transection of intrauterine adhesions
• Transection of intrauterine septa
• Endometrial ablation

The Hysteroscope System consists of a sterile single-use disposable Rigid Hysteroscope and video processor for clinical image processing. The Rigid Hysteroscope (available in models GSA01-B, GSB04-B and GSB14-B) are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Model GSA01-B is intended for diagnostic hysteroscopy only, and has a rigid shaft without operative channel (injection channel only). Models GSB04-B and GSB14-B are intended for both diagnostic and operative hysteroscopy, and have an operative (insertion) channel. GSB04-B has a rigid shaft, and GSB14-B has a curved tip. The video processor provides power and processes the images from the Rigid Hysteroscopes. Anatomical images are collected via a CMOS chip at the distal end of the hysteroscope and are transmitted through the video processor to a monitor.

The provided text is a 510(k) Summary for a Hysteroscope System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not include information about acceptance criteria and a study proving that the device meets those criteria in the way typically expected for a clinical performance study involving AI or human readers.

The performance data included in this document focuses on non-clinical testing performed to ensure the device's safety and effectiveness in relation to its physical and functional attributes. This is standard for medical devices like hysteroscopes, which are tools for visualization and surgical procedures, rather than AI-driven diagnostic or interpretative devices.

Therefore, the requested information elements related to AI, human readers, effect size, and specific ground truth establishment (like expert consensus, pathology, or outcomes data for complex diagnostic tasks) are not applicable to the content provided.

Here's the information that can be extracted or inferred from the document regarding acceptance criteria and performance data:

Acceptance Criteria and Device Performance for Shanghai AnQing Medical Instrument CO., Ltd. Hysteroscope System (K181545)

The acceptance criteria for the Hysteroscope System are based on engineering and performance standards relevant to a medical device of its type (a hysteroscope). The "study" proving acceptance criteria is a series of non-clinical tests.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for individual tests (e.g., how many hysteroscopes were tested for biocompatibility, optical performance, or mechanical performance). These are typically quality control or design verification tests, not clinical studies with patient data. Data provenance (country of origin, retrospective/prospective) is not applicable as these are laboratory and engineering tests, not patient data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of testing described. Ground truth for these engineering performance tests is established by adherence to recognized national and international standards (e.g., ISO, IEC) and internal design specifications, not by expert medical review of images or diagnoses.

4. Adjudication method for the test set
Not applicable. Adjudication methods like '2+1' or '3+1' are used in clinical studies involving interpretation of data (e.g., radiology images) by multiple experts to establish a consensus ground truth. The testing here is for physical/functional device performance against objective standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Hysteroscope System, a medical instrument for direct visualization and surgical procedures, not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and effect sizes related to AI assistance for human readers are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance data in this submission is adherence to established engineering, biocompatibility, sterilization, and electrical safety standards (e.g., ISO, IEC). It also includes meeting predefined internal design specifications for mechanical and optical functionality. There is no clinical "ground truth" (like pathology or outcomes data) in the context of diagnostic interpretation, as this device is a viewing and operative tool.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable.

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